Plus our top stories of the week

This Week

Nov 8, 2024

More M&A, or a shake-up at the FDA? Pharma braces for Trump's return to the White House


Kymera zeroes in on immunology, seeks partners for cancer candidates


Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings


Novo Nordisk discards kidney disease drug from $1.3B deal in wake of phase 3 fail


‘It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says


FDA clears its first treatment for dry AMD, with LumiThera’s light-based Valeda system

 

Featured

More M&A, or a shake-up at the FDA? Pharma braces for Trump's return to the White House

Over his first term, Donald Trump advocated for lower drug prices and pharmacy benefit manager reform. Now with the Inflation Reduction Act in play, what's to come for pharma under a Trump administration?
 

Top Stories

Kymera zeros in on immunology, seeks partners for cancer candidates

Kymera Therapeutics is pivoting its focus from oncology to immunology, with plans to only develop cancer programs beyond phase 1 through partnerships.

Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings

Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.

Novo Nordisk discards kidney disease drug from $1.3B deal in wake of phase 3 fail

Novo Nordisk, after mulling the implications of a phase 3 fail, has given up on a late-stage kidney drug acquired in a $1.3 billion deal.

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. Now, less than a year later, the FDA is reconsidering those serious safety warnings with plans to potentially change them, CBER Director Peter Marks, M.D., Ph.D., said in an interview with Fierce Pharma.

FDA clears its first treatment for dry AMD, with LumiThera’s light-based Valeda system

LumiThera’s Valeda system relies on photobiomodulation, or the use of different wavelengths of light to stimulate activity in the cells of the retina.

Novo pens $285M biobucks deal to use Ascendis' tech to create monthly GLP-1 agonist

Novo Nordisk has signed off on a $285 million biobucks deal with fellow Denmark-based company Ascendis Pharma to help the Wegovy manufacturer develop a once-monthly GLP-1 receptor agonist.

Dr. Reddy's pulls more than 300K bottles of thyroid drug, citing presence of a carcinogen

The U.S. unit of Indian drugmaker Dr. Reddy’s Laboratories is recalling 331,590 bottles of cinacalcet tablets used to treat hyperparathyroidism due to the presence of a known carcinogen.

Madrigal’s Rezdiffra has launched a new MASH market, but ‘tremendous change’ is on the horizon

With the FDA approval of the first specific drug for Metabolic Associated Steatohepatitis (MASH) in March this year, Madrigal’s Rezdiffra is a pioneer in a market set for rapid change.

Spanish gene editing biotech licenses DNA-cutting enzymes from Caszyme for up to $43M

Spanish biotech Integra Therapeutics has upped its arsenal of gene editing tools by licensing Caszyme’s Cas12I nucleases, the company announced Nov. 4.
 
Fierce podcasts

Don’t miss an episode

Drug pricing and the 2024 presidential election

This week on "The Top Line," we explore how each presidential candidate’s approach to drug pricing could shape future policy.
 

Resources

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Elevating Your Omnichannel Strategy with Programmatic EHR Advertising

Read this case study to discover how programmatic EHR advertising can transform your omnichannel marketing strategy.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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